Expert Medical Guidance for Regulatory Success
Medical Officer Consultants
Our Expert Consultants
Medical Officers
At xFDA, our consultants are former FDA medical officers, scientists, and regulatory experts with decades of experience in drug, biologic, and medical device development. With backgrounds in clinical medicine, epidemiology, toxicology, and regulatory affairs, our team provides strategic guidance to help clients navigate complex regulatory landscapes with confidence.
Meet Our Experts
xFDA’s Medical Officers are former FDA regulators and industry leaders with deep expertise in clinical research and compliance. We help pharmaceutical and biotech companies navigate complex regulatory challenges with confidence.
Medical Officer
Board-Certified Neurologist & Clinical Neurophysiologist | Former FDA Medical Reviewer
Expertise: Neurology, Pharmacovigilance, Clinical Trials, FDA Submissions
FDA Experience: Former Medical Reviewer, Division of Neuropsychopharmacological Drug Products
Industry Experience: 20+ years in clinical medicine, regulatory affairs, and pharmaceutical consulting
Dr. is a board-certified Neurologist with over 20 years of experience spanning clinical medicine, regulatory affairs, and pharmaceutical research. As a former FDA medical reviewer, he evaluated neuropsychopharmacological drug products and played a key role in clinical trial oversight.
In his industry tenure, he served as Vice-President of Clinical Research, leading teams to four successful NDA approvals. His expertise extends to pharmacovigilance, regulatory strategy, and business development. Currently, he provides consulting services for pharmaceutical companies, investment groups, and academic institutions, assisting with clinical holds, IND preparation, safety assessments, and due diligence evaluations.
Key Contributions:
Served as Medical Director, overseeing safety monitoring for 100+ drug products
Expert in IND, NDA, and clinical trial strategy
Advisor on FDA regulatory processes and risk assessment
Medical Officer
Medical Officer | Expert in Risk Assessment & Preventative Medicine
Expertise: Metabolism, Endocrinology, Risk Assessment, Preventative Medicine
FDA Experience: Former Medical Officer, Division of Metabolism and Endocrine Drug Products; Branch Chief, Division of Epidemiology and Surveillance
Industry Contributions: WHO Advisor, Research in Fertility Regulatory Methods
Dr. has extensive experience in regulatory risk assessment and preventative medicine. He served as a Medical Officer in the Division of Metabolism and Endocrine Drug Products and later as Branch Chief in the Division of Epidemiology and Surveillance at the FDA. His role included evaluating drug safety, conducting post-market surveillance, and advising on global health policies.
Key Contributions:
Advisor to WHO on fertility regulatory methods
Led epidemiological assessments for drug safety and effectiveness
Expert in risk assessment and regulatory compliance
Medical Officer
Board-Certified in Internal Medicine | Former FDA Medical Reviewer
Expertise: Clinical Trial Design, Drug & Biologic Evaluation, Medical Device Safety
FDA Experience: Medical Officer, Division of Blood Applications (CBER); Acting Director, Office of Surveillance and Biometrics (CDRH); Deputy Director, Office of AIDS and Special Health Concerns
Industry Contributions: Expert in drug safety, epidemiology, and medical device monitoring
Dr. has held several high-ranking positions within the FDA across multiple divisions. As Medical Officer for the Division of Blood Applications, he worked on clinical trial design for biologics and xenograft transplantation. Later, he led medical device safety surveillance as the Acting Director of the Office of Surveillance and Biometrics.
Key Contributions:
Led FDA oversight on medical device safety and drug effectiveness
Regulatory consultant for drugs, biologics, and devices
Expert in antiviral drug development for HIV and other viral pathogens
DVM, PhD
Toxicology & Pharmacology Expert | Former FDA Director, Division of Toxicology
Expertise: Veterinary Medicine, Pharmacology, Toxicology, FDA Compliance
FDA Experience: Director, Division of Toxicology, Center for Veterinary Medicine (CVM)
Industry Contributions: Consultant for pharmaceutical and food safety sectors
Dr. is a board-certified toxicologist with a PhD in Comparative Pharmacology and Toxicology. He served as Director of the Division of Toxicology at the FDA’s Center for Veterinary Medicine (CVM), advising pharmaceutical and food industries on regulatory compliance and new drug development.
Key Contributions:
Led FDA toxicology assessments for veterinary and human drug safety
Expert advisor on pharmacovigilance and regulatory strategy
Fluent in multiple languages (French, Greek, English, Italian, Spanish)
Medical Officer
Board-Certified in Gastroenterology | Former FDA Medical Reviewer
Expertise: Gastroenterology, Biosimilars, Orphan Drug Development, Regulatory Policy
FDA Experience: Medical Officer and Regulatory Scientist with over 30 years of experience in drug, biologic, device, and combination product evaluation
Industry Contributions: Leader in regulatory science, rare disease treatment development, and healthcare policy advancement
Dr. is a board-certified gastroenterologist with over three decades of experience spanning clinical medicine, biomedical research, and regulatory evaluation. He has worked extensively with the FDA on the development and review of drugs, biologics, medical devices, and combination products.
A thought leader in biosimilars and orphan drug development, Dr. [Name] also played a pivotal role in shaping FDA policies and regulatory science initiatives. He brings deep insight into regulatory frameworks, maintains an active medical license, and is known for his technical writing, public communication, and strategic leadership.
Key Contributions:
Over 30 years of regulatory and clinical expertise across multiple therapeutic areas
Former FDA policy advisor and medical reviewer for combination and orphan products
Expert in biosimilar development, rare disease treatment, and healthcare delivery policy
Why Our Medical Officers
xFDA’s Medical Officers bring decades of experience in regulatory review, clinical research, and pharmaceutical development. With backgrounds as former FDA regulators, industry executives, and subject matter experts, they provide invaluable insights to help clients navigate complex regulatory landscapes, ensuring compliance and successful product approvals.
What Sets Our Experts Apart:
Former FDA medical officers with hands-on regulatory experience
Board-certified specialists in neurology, infectious diseases, internal medicine, and more
Proven track record in NDA approvals, clinical trials, and pharmacovigilance
Expertise in drug, biologic, and medical device evaluation and compliance
Trusted advisors to global health organizations, including WHO
Don’t Wait to Get Started
Work with Our Experts
Our consultants bring unparalleled expertise to your regulatory challenges. Whether you need strategic guidance, FDA submission support, or expert advisory services, xFDA is here to help.
Need expert regulatory guidance? Contact us today to discuss your project needs with an xFDA consultant.